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Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01)

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ClinicalTrials.gov Identifier: NCT04142619
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Cellectis S.A.

Brief Summary:
This is a Phase I, FIH, open-label, dose escalation study evaluating Safety and Efficacy of UCART targeting CS1 in patients with Relapsed or Refractory Multiple Myeloma (MM). The purpose of this study is to evaluate the safety and clinical activity of UCARTCS1A and to determine the Maximum Tolerated Dose (MTD).

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Multiple Myeloma Biological: UCARTCS1A Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, Open-label Dose-escalation Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCARTCS1A (Allogenic Engineered T-cells Expressing Anti-CS1 Chimeric Antigen Receptor) Administered in Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : November 21, 2019
Estimated Primary Completion Date : May 18, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Dose Escalation
Several tested doses of UCARTCS1A until the Maximum Tolerated Dose (MTD) is identified.
Biological: UCARTCS1A
Allogenic engineered T-cells expressing anti- CS1 Chimeric Antigen Receptor




Primary Outcome Measures :
  1. Safety of UCARTCS1A [ Time Frame: 24 months. ]
    Incidence, nature and severity of adverse events and serious adverse events (SAEs) throughout the study.


Secondary Outcome Measures :
  1. Response Assessment [ Time Frame: 24 months ]
    At Day 35, Day 56 (M2), Day 84 (M3), Follow-up [Q3M up to Month 24; i.e., Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24

  2. Duration of Response [ Time Frame: 24 months ]
    Time Frame: From the date of the initial response to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24]

  3. Progression Free Survival [ Time Frame: 24 months ]
    From the first day of study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24

  4. Overall Survival [ Time Frame: 24 months ]
    From the first day of study treatment to the date of death from any cause, assessed up to Month 24



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with confirmed diagnosis of active multiple myeloma (as defined by International Myeloma Working Group [IMWG] criteria) who have relapsed/refractory disease after and have received at least 3 prior lines of prior therapy.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1;
  • No previous treatment with investigational gene targeting CS1 or chimeric antigen receptor therapy targeting CS1
  • Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within the screening period.
  • Other criteria may apply.

Exclusion Criteria:

  • Previous treatment with investigational gene therapy targeting CS1 or chimeric antigen receptor therapy targeting CS1;
  • Any cellular therapy (other than autologous or allogenic HSCT) within 60 days prior to enrollment;
  • Prior treatment with rituximab or other anti-CD20 therapy within 3 months
  • Any known active or uncontrolled infection
  • Autologous hematopoietic stem cell transplantation (HSCT) within 12 weeks prior to enrollment; any cellular therapy (other than autologous) within 60 days prior to enrollment; prior allogeneic HSCT.
  • Seropositive for Hepatitis C virus or positive for Hepatitis B surface antigen or core antibody.
  • Presence of active and clinically relevant central nervous system disorder, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, or organic brain syndrome.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142619


Contacts
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Contact: Cellectis Central Contact 3475790635 clinicaltrials@cellectis.com

Locations
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United States, California
UCSF Medical Center- Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Cellectis Central Contact         
Principal Investigator: Nina Shah         
United States, New Jersey
Hackensack Meridian Health Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Cellectis Central Contact         
United States, New York
Weill Cornell Medical College Withdrawn
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Krina Patel, Dr.         
Principal Investigator: Krina Patel         
Sponsors and Collaborators
Cellectis S.A.
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Responsible Party: Cellectis S.A.
ClinicalTrials.gov Identifier: NCT04142619    
Other Study ID Numbers: UCARTCS1A_01
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cellectis S.A.:
Multiple Myeloma
Chimeric Antigen Receptor T-Cell (CART-T) therapy
Transcription Activator-Like Effector Nuclease (TALEN)
Allogeneic
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases